Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of healthcare providers, is generally appropriate for an OAIC or a component of an OAIC if it meets the following two criteria, in addition to the criteria in the RFA that exclude a major focus on cognitive and behavioral research:

1. The research is a) designed to obtain new knowledge about the effects of interventions or healthcare practices that clearly specify what will be done for, or by, the individuals treated by these interventions or practices, OR b) designed to obtain new knowledge about the validity or predictive value of diagnostic or assessment techniques that clearly specify what will be measured in individuals. Examples of interventions or diagnostic strategies that may meet this criterion include:

New drug or hormonal intervention protocols that may require a new organizational strategy to deliver them

Disability prevention strategies based on application of treatment algorithms

Structured physical activity programs

New diagnostic measures for an age-related condition (e.g., tests for diastolic dysfunction)

Determining validity or predictive value of a functional assessment algorithm

2. The research is designed to determine health or risk factor effects relating to outcomes that are primarily clinical or functional (other than cognitive) in the individuals treated by the intervention or practice. Examples of outcomes include:

disease and risk factor outcomes, including diet and physical activity

functional outcomes

physiologic outcomes

Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of health care providers, would generally NOT be appropriate as a principal focus of an OAIC or OAIC component if EITHER of the following two criteria were met:

1. The research is NEITHER a) designed to obtain new knowledge about the effects of interventions that clearly specify what will be done for, or by, the individuals treated by the intervention or practice, NOR b) designed to obtain new knowledge about the validity or predictive value of diagnostic or assessment techniques that specify what will be measured in individuals. Examples of diagnostic or intervention research that would not generally be considered appropriate as a principal focus for an OAIC or component of an OAIC include:

Testing effects of a geriatric assessment unit or other new health care service, without both a) specification of the assessment protocol, criteria for deciding on appropriate treatment, a protocol for implementing treatment, and an adequate design to evaluate effects of these specific elements, and b) a design adequate to determine the effects of these specific components

Testing the effects of adding a new type of health professional (e.g., pharmacist) to a hospital service without both a) specification of the change in specific diagnostic or intervention procedures that would be implemented, and b) a design adequate to determine the effects of these specific changes

2. The research is not adequately designed to determine health or risk factor effects relating to outcomes that are primarily clinical or functional (other than cognitive) in the individuals treated by the intervention or practice. Examples of such research include:

Research designed to determine effects only on health care providers' behavior (e g., time spent per patient or number of diagnostic tests performed)

Research designed to determine effects only on patients' behavior (e.g., adherence to a set of dietary guidelines).